Notifications for European Union (1104 notifications)

Fine-tuning of some elements of the applicable Delegated Regulation (EU) 2020/686 based on experience with its implementation and towards better alignment with international standards. The changes concern definition and functions of an embryo collection team, de-regulation of germinal products of dogs and cats, testing for porcine reproductive and respiratory syndrome and classical swine fever, requirements for epizootic haemorrhagic disease and de-regulation of addition of antibiotics to semen.

This draft Commission Implementing Regulation provides that the approval of the active substance dimoxystrobin is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing dimoxystrobin as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the European Union under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC.This decision only concerns the placing on the market of this substance and plant protection products containing it. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, separate action will likely be taken on MRLs and a separate notification will be made in accordance with SPS procedures.This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/961.

The Regulation aligns the model certificates for the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption set out in Annex II to Implementing Regulation (EU) 2020/2236 to the new requirements in Article 166 of Commission Delegated Regulation (EU) 2020/692 as recently amended by Delegated Regulation (EU) 2023/119 as regards permitting aquatic animal health professionals to perform clinical inspections on consignments of aquatic animals prior to export to the Union provided they are authorised to do so under the law of the exporting third country or territory.

The assessment of the preparations of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, endo-1,3-beta-glucanase from Aspergillus neoniger MUCL 39199, endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 shows that the conditions for their authorisation as feed additive, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations was authorised by a Commission Implementing Regulation that is the subject of this notification.

The application concerns the authorisation of a preparation of Pediococcus acidilactici CNCM I-4622 as a feed additive for all animal species, to be classified in the additive category ‘technological additives’ and in the functional groups ‘acidity regulators’ and ‘hygiene condition enhancers’.The European Food Safety Authority concluded in its opinion of 29 June 2022 that, under the proposed conditions of use, the preparation of Pediococcus acidilactici CNCM I-4622 does not have adverse effects on animal health, consumer safety or the environment. It also concluded that it is considered a respiratory sensitiser. It further concluded that the preparation showed a potential to reduce the pH and the growth of coliforms in liquid feeds. The preparation of Pediococcus acidilactici CNCM I-4622 thus satisfies the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of this preparation was authorised, specifying that appropriate protective measures be taken to prevent adverse effects for users of the additive.

The notification concerns the renewal of the authorisation of naringin, a feed additive authorised for a period of 10 years for all animal species by Commission Implementing Regulation (EU) No 870/2012. In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of naringin as a feed additive for all animal species, in the additive category ‘sensory additives’ and in the functional group 'flavouring compounds’. The assessment of naringin showed that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, were satisfied. As a consequence, the authorisation of that additive was renewed.To allow better control, a recommended maximum content will have to be indicated on the label of the additive. As a consequence of the renewal of the authorisation of naringin as a feed additive, Implementing Regulation (EU) No 870/2012 was repealed.

The proposal notified in G/SPS/N/EU/582 (21 July 2022) is now adopted by Commission Regulation (EU) 2023/147 of 20 January 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyromazine, topramezone and triflumizole in or on certain products (Text with EEA relevance) [OJ L 20, 23 January 2023, p. 1].This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Vitamin E was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 26/2011. In accordance with Article 14 of Regulation (EC) No 1831/2003, five applications were submitted for the renewal of the authorisation of vitamin E in the form of all-rac-alpha-tocopheryl acetate and one for the renewal of the authorisation of vitamin E in the form of RRR-alpha-tocopheryl acetate as feed additives for all animal species, in the additive category ‘nutritional additives’ and the functional group ‘vitamins, pro-vitamins and chemical well-defined substances having similar effect’. As a consequence of the renewal of the authorisation of vitamin E in the form of all-rac-alpha-tocopheryl acetate and of vitamin E in the form of RRR-alpha-tocopheryl acetate as feed additives, as well as the expiry of the authorisation of vitamin E in the form of RRR-alpha-tocopherol, Regulation (EU) No 26/2011 is repealed. Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of vitamin E, a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation is provided for.

The preparations of Lactiplantibacillus plantarum DSM 21762, previously taxonomically identified as Lactobacillus plantarum (DSM 21762), of Lactiplantibacillus plantarum NCIMB 30236, previously taxonomically identified as Lactobacillus plantarum (NCIMB 30236) and of Lactococcus lactis NCIMB 30117 were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulations (EU) No 868/2011, (EU) No 1111/2011 and (EU) No 227/2012, respectively. In accordance with Article 14 of Regulation (EC) No 1831/2003, applications were submitted for the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 21762, of Lactiplantibacillus plantarum NCIMB 30236 and of Lactococcus lactis NCIMB 30117 as feed additives for all animal species, requesting the additives to be classified in the additive category ‘technological additives’. Those applications were accompanied by the particulars and documents required under that Article. The assessment of the preparations of Lactiplantibacillus plantarum DSM 21762, of Lactiplantibacillus plantarum NCIMB 30236 and of Lactococcus lactis NCIMB 30117 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of those additives should be renewed.

The notification concerns the authorisation of the preparation of Pediococcus pentosaceus DSM 32292 as a feed additive for all animal species, classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’The European Food Safety Authority concluded in its opinion of 29 June 2022 that, under the proposed conditions of use, the preparation of Pediococcus pentosaceus DSM 32292 does not have an adverse effect on animal health, consumer safety or the environment. As the assessment of the preparation of Pediococcus pentosaceus DSM 32292 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied, the preparation was authorised.

Regulation (EU) 2019/1871 on reference points for action (RPA) for non-allowed pharmacologically active substances present in food of animal origin establishes reference points for action (RPAs) for certain prohibited substances, which will become applicable as from 28 November 2022. The draft Regulation provides for an exemption of the application of the RPA for semicarbazide (SEM) in certain products under strict conditions.

The proposal notified in G/SPS/N/EU/597 (6 September 2022) is now adopted by Commission Regulation (EU) 2023/466 of 3 March 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, novaluron and tetraconazole in or on certain products (Text with EEA relevance) [OJ L 68, 6 March 2023, p. 55].The Regulation shall apply from 26 September 2023.

The proposal notified in G/SPS/N/EU/566 (13 May 2022) is now adopted by Commission Regulation (EU) 2023/465 of 3 March 2023 amending Regulation (EC) No 1881/2006 as regards maximum levels of arsenic in certain foods (Text with EEA relevance) [OJ L 68, 6 March 2023, p. 51].This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

The proposal notified in G/SPS/N/EU/581 (21 July 2022) is now adopted by Commission Regulation (EU) 2023/377 of 15 February 2023 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benzalkonium chloride (BAC), chlorpropham, didecyldimethylammonium chloride (DDAC), flutriafol, metazachlor, nicotine, profenofos, quizalofop-P, sodium aluminium silicate, thiabendazole and triadimenol in or on certain products (Text with EEA relevance) [OJ L 55, 22 February 2023, p. 1].The Regulation shall apply from 14 September 2023.

The proposed draft Regulation concerns the review of existing MRLs for denatonium benzoate, diuron, etoxazole, methomyl and teflubenzuron in certain food commodities following the non-approval of these substances for use on edible crops in the European Union. MRLs for these substances in certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union and for which a human health concern may not be excluded.

The proposed draft Regulation concerns the review of existing MRLs for pyriproxyfen in certain food commodities. MRLs for these substances in certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union.

The proposed draft Regulation concerns the update of existing MRLs for carbetamide, carboxin and triflumuron in certain food commodities. MRLs for these substances in certain commodities are changed. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union as the approval of the use of the active substance has expired.

This Regulation is a measure transposing Codex MRLs (CXLs), for which the European Union has not reserved its position in the 52nd Codex Committee for Pesticides Residues (CCPR), into EU legislation.

The proposal notified in G/SPS/N/EU/575 (4 July 2022) is now adopted by Commission Regulation (EU) 2023/128 of 18 January 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benalaxyl, bromoxynil, chlorsulfuron, epoxiconazole and fenamiphos in or on certain products (Text with EEA relevance) [OJ L 17, 19 January 2023, p. 22].The Regulation shall apply y from 8 August 2023.

The purpose of this Regulation is to extend the list of shelf-stable composite products that are exempted from official controls at border control posts in Delegated Regulation (EU) 2021/630 by including spreads and preparations for making beverages containing cocoa, products obtained from cereals or cereal products, prepared foods from rice and other cereals, certain chips and crisps, miso and soy sauce containing a small amount of fish soup stock.Since the Annex of Delegated Regulation (EU) 2021/630 is amended to include new composite products exempted from official controls at border control posts the Delegated Regulation (EU) 2019/2122 is amended accordingly to:Include the list of new composite products in posters in all points of entry into the Union;Exempt new composite products from official controls at border control posts when they form part of passengers’ personal luggage.